Implementing Patient-Centered Outcomes Research Institute Stakeholder Engagement Principles in Models of Palliative Care Delivery and Advance Care Planning Research.

BACKGROUND: Given the many challenges of conducting research that addresses the palliative and end-of-life care needs of patients with serious illnesses, stakeholder engagement starting from the moment of study conceptualization and design is critical to ensure successful participant recruitment, data collection, intervention delivery, data analysis, and dissemination. METHODS: Guided by a conceptual model published by the Patient-Centered Outcomes Research Institute (PCORI) entitled, "Measuring What Matters for Advancing the Science and Practice of Engagement"14 and with the support of a PCORI Engagement Officer, representatives from 9 PCORI-funded study teams formed a working group to survey team members and review, outline, and describe key lessons learned and best practices for promoting stakeholder engagement in palliative care research. RESULTS: Almost all study teams engaged with patients/caregivers, clinicians, researchers, and health care system experts as stakeholder partners. About half the teams also included payers and training institutions as part of their stakeholder advisors as well as a range of content experts. Study teams relied on a variety of support structures and resources, and they employed 10 distinct methods for maintaining engagement. All engagement methods were generally considered to be effective by teams who used the method, though there was some variability in team-rated engagement quality of each method. Nine barriers to stakeholder engagement were identified across the 9 studies as well as 9 strategies (or facilitators) to overcome these barriers. We share examples of how stakeholder engagement impacted studies in all phases, including the preparatory phase, study initiation phase, execution phase, and data analysis/dissemination phase. CONCLUSIONS: Teams utilized a variety of resources and support structures as well as capitalized on multiple engagement methods for fostering stakeholder engagement, resulting in a high level of collaboration and integration.

Standard HIPAA Authorization Forms Decreased Response Rates for a Multi-site Pragmatic Trial.

BACKGROUND: The Health Insurance Portability and Accountability Act (HIPAA) aims to safeguard patient information; however, complex legal language may lead to confusion and mistrust, and hinder enrollment in clinical trials. OBJECTIVE: To evaluate the effect of a standard HIPAA authorization included in mailed survey packets on study enrollment for a multi-site pragmatic trial. DESIGN: This study is nested within an advance care planning pragmatic trial at 50 primary care clinics across three University of California (UC) Health Systems. PARTICIPANTS: We included English and Spanish-speaking seriously ill patients. INTERVENTIONS: One third of eligible patients received and 2/3 did not receive the HIPAA authorization in their enrollment packet. MAIN MEASURES: We compared enrollment rates at 3 months and assessed the readability, understandability, and actionability of the standard HIPAA form using the Federal Plain Language Guidelines Checklist for Plain Language, the Automatic Readability Checker consensus calculator (grade 8 is the average reading level for US adults), and the Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P, 0-100%, 70% considered the minimum). KEY RESULTS: Of 4632 eligible patients (mean age 71, 48% women, 11% Spanish-speaking, 40% racial/ethnic minority); 1543 received a mailed enrollment packet with a HIPAA form and 3089 did not. Patients mailed the HIPAA form were less likely to enroll (10.2% vs. 14.8%, p < 0.001). The standard HIPAA form scored at the 12th grade reading level, had a PEMAT-P Understandability score of 42%, had an Actionability score of 40%, and only met 50% of Federal Plain Language Guideline Checklist items. CONCLUSIONS: The inclusion of a standard HIPAA authorization in mailed enrollment packets for a large pragmatic trial led to lower rates of study enrollment. This study informs how HIPAA authorization forms should be redesigned to be more accessible to patients to prevent unnecessary barriers to research enrollment.

Surgeon-reported Factors Influencing Adoption of Quality Standards for Goal-concordant Care in Patients With Advanced Cancer: A Qualitative Study.

OBJECTIVE: This study explored surgical oncologists' perspectives on factors influencing adoption of quality standards in patients with advanced cancer. BACKGROUND: The American College of Surgeons Geriatric Surgery Verification Program includes communication standards designed to facilitate goal-concordant care, yet little is known about how surgeons believe these standards align with clinical practice. METHODS: Semistructured video-based interviews were conducted from November 2020 to January 2021 with academic surgical oncologists purposively sampled based on demographics, region, palliative care certification, and years in practice. Interviews addressed: (1) adherence to standards documenting care preferences for life-sustaining treatment, surrogate decision-maker, and goals of surgery; and (2) factors influencing their adoption into practice. Interviews were audio-recorded, transcribed, qualitatively analyzed, and conducted until thematic saturation was reached. RESULTS: Twenty-six surgeons participated (57.7% male, 8.5 mean years in practice, 19.2% palliative care board-certified). Surgeons reported low adherence to documenting care preferences and surrogate decision-maker and high adherence to discussing, but not documenting, goals of surgery. Participants held conflicting views about the relevance of care preferences to preoperative conversations and surrogate decision-maker documentation by the surgeon and questioned the direct connection between documentation of quality standards and higher value patient care. Key themes regarding factors influencing adoption of quality standards included organizational culture, workflow, and multidisciplinary collaboration. CONCLUSIONS: Although surgeons routinely discuss goals of surgery, documentation is inconsistent; care preferences and surrogate decision-makers are rarely discussed or documented. Adherence to these standards would be facilitated by multidisciplinary collaboration, institutional standardization, and evidence linking standards to higher value care.

Quality measures in HCC care by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

The burden of HCC is substantial. To address gaps in HCC care, the American Association for the Study of Liver Diseases (AASLD) Practice Metrics Committee (PMC) aimed to develop a standard set of process-based measures and patient-reported outcomes (PROs) along the HCC care continuum. We identified candidate process and outcomes measures for HCC care based on structured literature review. A 13-member panel with content expertise across the HCC care continuum evaluated candidate measures on importance and performance gap using a modified Delphi approach (two rounds of rating) to define the final set of measures. Candidate PROs based on a structured scoping review were ranked by 74 patients with HCC across 7 diverse institutions. Out of 135 measures, 29 measures made the final set. These covered surveillance (6 measures), diagnosis (6 measures), staging (2 measures), treatment (10 measures), and outcomes (5 measures). Examples included the use of ultrasound (± alpha-fetoprotein [AFP]) every 6 months, need for surveillance in high-risk populations, diagnostic testing for patients with a new AFP elevation, multidisciplinary liver tumor board (MLTB) review of Liver Imaging-Reporting and Data System 4 lesions, standard evaluation at diagnosis, treatment recommendations based on Barcelona Clinic Liver Cancer staging, MLTB discussion of treatment options, appropriate referral for evaluation of liver transplantation candidacy, and role of palliative therapy. PROs include those related to pain, anxiety, fear of treatment, and uncertainty about the best individual treatment and the future. The AASLD PMC has developed a set of explicit quality measures in HCC care to help bridge the gap between guideline recommendations and measurable processes and outcomes. Measurement and subsequent implementation of these metrics could be a central step in the improvement of patient care and outcomes in this high-risk population.

The 3 Wishes Program Improves Families' Experience of Emotional and Spiritual Support at the End of Life.

BACKGROUND: The end-of-life (EOL) experience in the intensive care unit (ICU) is emotionally challenging, and there are opportunities for improvement. The 3 Wishes Program (3WP) promotes the dignity of dying patients and their families by eliciting and implementing wishes at the EOL. AIM: To assess whether the 3WP is associated with improved ratings of EOL care. PROGRAM DESCRIPTION: In the 3WP, clinicians elicit and fulfill simple wishes for dying patients and their families. SETTING: 2-hospital academic healthcare system. PARTICIPANTS: Dying patients in the ICU and their families. PROGRAM EVALUATION: A modified Bereaved Family Survey (BFS), a validated tool for measuring EOL care quality, was completed by families of ICU decedents approximately 3 months after death. We compared patients whose care involved the 3WP to those who did not using three BFS-derived measures: Respectful Care and Communication (5 questions), Emotional and Spiritual Support (3 questions), and the BFS-Performance Measure (BFS-PM, a single-item global measure of care). RESULTS: Of 314 completed surveys, 117 were for patients whose care included the 3WP. Bereaved families of 3WP patients rated the Emotional and Spiritual Support factor significantly higher (7.5 vs. 6.0, p = 0.003, adjusted p = 0.001) than those who did not receive the 3WP. The Respectful Care and Communication factor and BFS-PM were no different between groups. DISCUSSION: The 3WP is a low-cost intervention that may be a feasible strategy for improving the EOL experience.

Telephone Outreach Enhances Recruitment of Underrepresented Seriously Ill Patients for an Advance Care Planning Pragmatic Trial.

BACKGROUND: Patients experiencing systemic patterns of disadvantage, such as racial/ethnic minorities and those with limited English proficiency, are underrepresented in research. This is particularly true for large pragmatic trials of potentially sensitive research topics, such as advance care planning (ACP). It is unclear how phone outreach may affect research participation by underrepresented individuals. OBJECTIVE: To assess the effect of phone outreach, in addition to standard mail survey recruitment, in a population-based ACP pragmatic trial at three academic health systems in California. DESIGN: Retrospective cohort study PATIENTS: Primary care patients with serious illness were mailed a survey in their preferred language. Patients who did not initially respond by mail received up to three reminder phone calls with the option of survey completion by phone. MAIN MEASURES: Effect of phone outreach on survey response rate associated with respondent demographic characteristics (e.g., Social Vulnerability Index [SVI], range 0 (low) to 1 (high)). RESULTS: Across the health systems, 5998 seriously ill patients were mailed surveys. We obtained completed surveys from 1215 patients (20% response rate); 787 (65%) responded after mail alone and 428 (35%) participated only after phone outreach. Patients recruited after phone outreach compared to mail alone were more socially vulnerable (SVI 0.41 v 0.35, P < 0.001), were more likely to report being a racial/ethnic minority (35% v 28%, P = 0.006), and non-English speaking (16% v 10%, P = 0.005). Age and gender did not differ significantly. The inclusion of phone outreach resulted in a sample that better represented the baseline population than mail alone in racial/ethnic minority (28% mail alone, 30% including phone outreach, 36% baseline population), non-English language preference (10%, 12%, 15%, respectively), and SVI (0.35, 0.37, 0.38, respectively). CONCLUSIONS: Phone outreach for a population-based survey in a pragmatic trial concerning a potentially sensitive topic significantly enhanced recruitment of underrepresented seriously ill patients.

Improving Serious Illness Care for Surgical Patients: Quality Indicators for Surgical Palliative Care.

OBJECTIVE: Develop quality indicators that measure access to and the quality of primary PC delivered to seriously ill surgical patients. SUMMARY OF BACKGROUND DATA: PC for seriously ill surgical patients, including aligning treatments with patients' goals and managing symptoms, is associated with improved patient-oriented outcomes and decreased healthcare utilization. However, efforts to integrate PC alongside restorative surgical care are limited by a lack of surgical quality indicators to evaluate primary PC delivery. METHODS: We developed a set of 27 preliminary indicators that measured palliative processes of care across the surgical episode, including goals of care, decision-making, symptom assessment, and issues related to palliative surgery. Then using the RAND-UCLA Appropriateness method, a 12-member expert advisory panel rated the validity (primary outcome) and feasibility of each indicator twice: (1) remotely and (2) after an in-person moderated discussion. RESULTS: After 2 rounds of rating, 24 indicators were rated as valid, covering the preoperative evaluation (9 indicators), immediate preoperative readiness (2 indicators), intraoperative (1 indicator), postoperative (8 indicators), and end of life (4 indicators) phases of surgical care. CONCLUSIONS: This set of quality indicators provides a comprehensive set of process measures that possess the potential to measure high quality PC for seriously ill surgical patients throughout the surgical episode.

Patient and Caregiver Prioritization of Palliative and End-of-Life Cancer Care Quality Measures.

BACKGROUND: Development and prioritization of quality measures typically relies on experts in clinical medicine, but patients and their caregivers may have different perspectives on quality measurement priorities. OBJECTIVE: To inform priorities for health system implementation of palliative cancer and end-of-life care quality measures by eliciting perspectives of patients and caregivers. DESIGN: Using modified RAND-UCLA Appropriateness Panel methods and materials tailored for knowledgeable lay participants, we convened a panel to rate cancer palliative care process quality measure concepts before and after a 1-day, in-person meeting. PARTICIPANTS: Nine patients and caregivers with experience living with or caring for patients with cancer. MAIN MEASURES: Panelists rated each concept on importance for providing patient- and family-centered care on a nine-point scale and each panelist nominated five highest priority measure concepts ("top 5"). KEY RESULTS: Cancer patient and caregiver panelists rated all measure concepts presented as highly important to patient- and family- centered care (median rating ≥ 7) in pre-panel (mean rating range, 6.9-8.8) and post-panel ratings (mean rating range, 7.2-8.9). Forced choice nominations of the "top 5" helped distinguish similarly rated measure concepts. Measure concepts nominated into the "top 5" by three or more panelists included two measure concepts of communication (goals of care discussions and discussion of prognosis), one measure concept on providing comprehensive assessments of patients, and three on symptoms including pain management plans, improvement in pain, and depression management plans. Patients and caregivers nominated one additional measure concept (pain screening) back into consideration, bringing the total number of measure concepts under consideration to 21. CONCLUSIONS: Input from cancer patients and caregivers helped identify quality measurement priorities for health system implementation. Forced choice nominations were useful to discriminate concepts with the highest perceived importance. Our approach serves as a model for incorporating patient and caregiver priorities in quality measure development and implementation.

NCCN Guidelines® Insights: Palliative Care, Version 2.2021.

Palliative care has evolved to be an integral part of comprehensive cancer care with the goal of early intervention to improve quality of life and patient outcomes. The NCCN Guidelines for Palliative Care provide recommendations to help the primary oncology team promote the best quality of life possible throughout the illness trajectory for each patient with cancer. The NCCN Palliative Care Panel meets annually to evaluate and update recommendations based on panel members' clinical expertise and emerging scientific data. These NCCN Guidelines Insights summarize the panel's recent discussions and highlights updates on the importance of fostering adaptive coping strategies for patients and families, and on the role of pharmacologic and nonpharmacologic interventions to optimize symptom management.

Exploring expanded interdisciplinary roles in goals of care conversations in a national goals of care initiative: A qualitative approach.

BACKGROUND: The United States Veterans Health Administration National Center for Ethics in Health Care implemented the Life-Sustaining Treatment Decisions Initiative throughout the Veterans Health Administration health care system in 2017. This policy encourages goals of care conversations, referring to conversations about patient's treatment and end-of-life wishes for life-sustaining treatments, among Veterans with serious illnesses. A key component of the initiative is expanding interdisciplinary provider roles in having goals of care conversations. AIM: Use organizational role theory to explore medical center experiences with expanding interdisciplinary roles in the implementation of a goals of care initiative. DESIGN: A qualitative thematic analysis of semi-structured interviews. SETTING/PARTICIPANTS: Initial participants were recruited using purposive sampling of local medical center champions. Snowball sampling identified additional participants. Participants included thirty-one interdisciplinary providers from 12 geographically diverse initiative pilot and spread medical centers. RESULTS: Five themes were identified. Expanding provider roles in goals of care conversations (1) involves organizational culture change; (2) is influenced by medical center leadership; (3) is supported by provider role readiness; (4) benefits from cross-disciplinary role agreement; and (5) can "overwhelm" providers. CONCLUSIONS: Organizational role theory is a helpful framework for exploring interdisciplinary roles in a goals of care initiative. Support and recognition of provider role expansion in goals of care conversations was important for the adoption of a goals of care initiative. Actionable strategies, including multi-level leadership support and the use of interdisciplinary champions, facilitate role change and have potential to strengthen uptake of a goals of care initiative.

Integrated Model for Patient-Centered Advanced Liver Disease Care.

Advanced liver disease (AdvLD) is a high-risk common condition with a progressive, highly morbid, and often fatal course. Despite effective treatments, there are substantial shortfalls in access to and use of evidence-based supportive and palliative care for AdvLD. Although patient-centered, chronic illness models that integrate early supportive and palliative care with curative treatments hold promise, there are several knowledge gaps that hinder development of an integrated model for AdvLD. We review these evidence gaps. We also describe a conceptual framework for a patient-centered approach that explicates key elements needed to improve integrated care. An integrated model of AdvLD would allow clinicians, patients, and caregivers to work collaboratively to identify treatments and other healthcare that best align with patients' priorities.

Palliative Care and Health Care Utilization for Patients With End-Stage Liver Disease at the End of Life.

BACKGROUND & AIMS: There has been increased attention on ways to improve the quality of end-of-life care for patients with end-stage liver disease; however, there have been few reports of care experiences for patients during terminal hospitalizations. We analyzed data from a large national database to increase our understanding of palliative care for and health care utilization by patients with end-stage liver disease. METHODS: We performed a cross-sectional, observational study to examine terminal hospitalizations of adults with decompensated cirrhosis using data from the National Inpatient Sample from 2009 through 2013. We collected data on palliative care consultation and total hospital costs, and performed multivariate regression analyses to identify factors associated with palliative care consultation. We also investigated whether consultation was associated with lower costs. RESULTS: Among hospitalized adults with terminal decompensated cirrhosis, 30.3% received palliative care; the mean cost per hospitalization was $48,551 ± $1142. Palliative care consultation increased annually, and was provided to 18.0% of patients in 2009 and to 36.6% of patients in 2013 (P < .05). The mean cost for the terminal hospitalization did not increase significantly ($47,969 in 2009 to $48,956 in 2013, P = .77). African Americans, Hispanics, Asians, and liver transplant candidates were less likely to receive palliative care, whereas care in large urban teaching hospitals was associated with a higher odds of receiving consultation. Palliative care was associated with lower procedure burden-after adjusting for other factors, palliative care was associated with a cost reduction of $10,062. CONCLUSIONS: Palliative care consultation for patients with end-stage liver disease increased from 2009 through 2013. Palliative care consultation during terminal hospitalizations is associated with lower costs and procedure burden. Future research should evaluate timing and effects of palliative care on quality of end-of-life care in this population.

Bolstering Advance Care Planning Measurement Using Natural Language Processing.

Despite its growth as a clinical activity and research topic, the complex dynamic nature of advance care planning (ACP) has posed serious challenges for researchers hoping to quantitatively measure it. Methods for measurement have traditionally depended on lengthy manual chart abstractions or static documents (e.g., advance directive forms) even though completion of such documents is only one aspect of ACP. Natural language processing (NLP), in the form of an assisted electronic health record (EHR) review, is a technological advancement that may help researchers better measure ACP activity. In this article, we aim to show how NLP-assisted EHR review supports more accurate and robust measurement of ACP. We do so by presenting three example applications that illustrate how using NLP for this purpose supports (1) measurement in research, (2) detailed insights into ACP in quality improvement, and (3) identification of current limitations of ACP in clinical settings.

What Patients Facing Cancer and Caregivers Want From Communication in Times of Crisis: A Qualitative Study in the Early Months of the COVID-19 Pandemic.

BACKGROUND: Interpersonal communication is a cornerstone of patient-centered care. We aimed to identify what patients with cancer and caregivers may want from communication during a public health crisis. METHODS: We interviewed 15 patients (8 Veteran, 7 non-Veteran) and caregivers from regionally, racially, and ethnically diverse backgrounds across the US about serious illness care and quality of care during the COVID-19 pandemic Using an iterative, inductive and deductive process, 2 coders analyzed content associated with the code "Communication," which appeared 71 times, and identified 5 themes. RESULTS: Participants identified as White (10), Latino/a (3), Asian (1), and Black (1). (1) Help patients and caregivers prepare for care during crisis by communicating medical information directly and proactively. (2) Explain how a crisis might influence medical recommendations and impact on recovery from illness. (3) Use key messengers to improve communication between primary teams, patients, and caregivers. (4) Include caregivers and families in communication when they cannot be physically present. (5) Foster bidirectional communication with patients and families to engage them in shared decision-making during a vulnerable time. CONCLUSION: Communication is critical during a public health crisis yet overwhelmed clinicians may not be able to communicate effectively. Communicating with caregivers and family, transparent and timely communication, ensuring diverse providers are on the same page, and effective listening are known gaps even before the COVID-19 pandemic. Clinicians may need quick interventions, like education about goals of care, to remind them about what seriously ill patients and their caregivers want from communication and offer patient-centered care during crises.

Limitations With California Medicaid Data for Palliative and End of Life Care Quality Measures.

In 2014 the California legislature passed Senate Bill 1004 (SB 1004) that was designed to expand access to specialty palliative care for individuals served by California's Medicaid (known as Medi-Cal) Managed Care Plans (MCPs). The California Department of Health Care Services (DHCS) operationalized the legislation by developing minimum requirements for palliative care programs that all MCPs must meet or exceed.7 Quality and utilization data specific to California's Medicaid population are needed for stakeholders to identify care deficiencies and disparities, describe the end of life experience and utilization patterns of MCP members, compare these patterns to Medicare beneficiaries or other populations, and set appropriate targets to help monitor progress. We evaluated the feasibility of using Medicaid claims data and encounter data either by partnering with MCPs or by obtaining statewide data from DHCS to measure the quality of palliative care and end of life care. In a concurrent but separate effort, we analyzed administrative data supplied by three MCPs as part of a prospective pilot of standards for home-based palliative care in California, including care delivered to Medicaid beneficiaries under SB 1004. Beyond the practical challenges of allowing time for data access and approvals, both projects revealed several limitations to using administrative data to assess quality of palliative and end of life care for a Medicaid population. We describe these challenges that undermined our confidence in analysis results and propose solutions to measuring the quality of palliative and end of life care for Medicaid patients and suggested next steps.